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智能康复辅助系统促进老年股骨颈骨折半髋关节置换术后早期功能恢复:一项随机对照试验方案

Intelligent rehabilitation assistant system to promote the early functional recovery of the elderly patients with femoral neck fracture after hemiarthroplasty (HA): A protocol for a randomized controlled trial.

作者信息

Li Zige, Lin Haixiong, Wang Xiaotong, Huang Minling, Feng Junming, Feng Junjie, Gao Junyan, Wu Jingjing, Jiang Ziwei

机构信息

The First School of Clinical Medicine.

Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine.

出版信息

Medicine (Baltimore). 2020 Nov 13;99(46):e23078. doi: 10.1097/MD.0000000000023078.

Abstract

BACKGROUND

Femoral neck fracture is a common type of hip fracture, which has a high morbidity and mortality. Surgical treatment is the first choice. However, the functional rehabilitation after operation has not been paid enough attention. In addition, the quality of exercise is difficult to quantify, and the rehabilitation is lack of standards. Therefore, the intelligent rehabilitation assistant system which could record exercise details, might be used to evaluate the quality and adherence to the prescribed exercise to this fragile group of patients has great relevance, so as to provide new ideas for postoperative rehabilitation of hip fracture.

METHODS

This is an opening, prospective, double-dummy RCT. Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study. The sample will be divided into monitoring group and control group randomly at a 1:1 ratio. The prescribed exercises need to be done continuously for 2 weeks. The monitoring group needs additional use intelligent rehabilitation assistant system. Each subject will receive a total of 4 follow-up visits at the designated time (2 weeks, 4 weeks, 12 weeks, and 24 weeks). The following factors will be talked as dependent variables:Each subject will receive a total of 4 follow-up visits at the designated time, and the findings will be analyzed statistically considering a 5% significance level (P < .05).

DISCUSSION

Exercise under monitor may improve patients compliance and exercise quality, and accelerate the rehabilitation process. This protocol reported in accordance with the CONSORT 2010 checklist and SPIRIT 2013 Checklist.

TRIAL REGISTRATION

The trial is registered at Chinese Clinical Trials Registry (ChiCTR2000033213, May 24, 2020).

摘要

背景

股骨颈骨折是髋部骨折的常见类型,发病率和死亡率较高。手术治疗是首选。然而,术后的功能康复尚未得到足够重视。此外,运动质量难以量化,康复缺乏标准。因此,能够记录运动细节的智能康复辅助系统,对于评估这一脆弱患者群体规定运动的质量和依从性具有重要意义,可为髋部骨折术后康复提供新思路。

方法

这是一项开放性、前瞻性、双盲随机对照试验。将邀请50例年龄大于65岁且即将因髋部骨折住院的股骨颈骨折患者参与研究。样本将按1:1比例随机分为监测组和对照组。规定的运动需持续进行2周。监测组需要额外使用智能康复辅助系统。每位受试者将在指定时间(2周、4周、12周和24周)共接受4次随访。以下因素将作为因变量进行讨论:每位受试者将在指定时间共接受4次随访,研究结果将在5%显著性水平(P<0.05)下进行统计学分析。

讨论

在监测下进行运动可能会提高患者的依从性和运动质量,并加速康复进程。本方案按照CONSORT 2010清单和SPIRIT 2013清单进行报告。

试验注册

该试验已在中国临床试验注册中心注册(ChiCTR2000033213,2020年5月24日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7140/7668524/7c5b6cba0942/medi-99-e23078-g001.jpg

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